Kornimate/medical-research-clean huggingface dataset:
closing the loop in adults with type 1 diabetes - alcohol consumption

Conditions: Type 1 Diabetes

Summary: the main objective is to assess the efficacy and safety of overnight automated closed loop glucose control using a computer-based algorithm compared with conventional insulin pump therapy in adults with type 1 diabetes following the consumption of a moderate amount of alcohol at dinnertime.

people with type 1 diabetes need regular insulin injections or continuous delivery of insulin using an insulin pump. keeping blood sugars in the normal range is known to reduce the risk of long term complications involving the eyes, kidneys and heart. however, achieving treatment goals can be very difficult as the tighter we try to control blood glucose levels, the greater the risk of the person developing episodes of low glucose levels (hypoglycaemia). one solution is using a system where the amount of insulin injected closely matches the blood sugar levels on a continuous basis. this can be achieved by what is known as a "closed loop system" where a small glucose sensor placed under the skin communicates with a computer containing an algorithm that drives a subcutaneous insulin pump. this system is being developed in cambridge and is undergoing trials in children and adults with type 1 diabetes. results thus far show that the system is very effective at preventing hypoglycaemia and maintaining blood glucose levels in target range. we plan to test the closed loop in various challenging conditions faced by patients in daily life. one of these is the consumption of alcohol, which can give rise to delayed hypoglycaemia in patients with diabetes. the studies will be done in a clinical research facility under supervised conditions. subjects will attend for two study nights where they will receive a specific volume of alcohol with an evening meal. on one night this will be followed by closed loop algorithm control of their insulin overnight. on the other (control) night subjects will remain on their usual pump therapy regime overnight.

Eligibility criteria:
inclusion criteria: * type 1 diabetes, as defined by who for at least 6 months or confirmed c-peptide negative * on insulin pump therapy for at least 3 months exclusion criteria: * non-type 1 diabetes mellitus * any physical/psychological disease likely to interfere with the study * taking medication likely to interfere with interpretation of results * known/suspected allergy against insulin * clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator * unstable blood glucose control, including recurrent severe hypoglycaemia as judged by the investigator * current pregnancy/breastfeeding * total daily insulin dose \> 1.4 iu/kg * hba1c \> 10% within the last 3 months * unable/unwilling to consume the necessary quantity of alcohol stated in the study protocol
generic plerixafor efficacy of autologous hematopoietic stem cell transplantation

Conditions: Lymphoma; Myeloma

Summary: generic plerixafor use at reduced-dose for mobilization on hsct transplant

the objective of this study is to demonstrate that the use of a low dose of the generic form of a drug called plerixafor is effective in increasing the amount of hematopoietic cells (stem cells) in your blood, which will then be collected for your transplant. plerixafor is a very effective medicine that is already used for this purpose, however its high cost limits its use in all patients.

Eligibility criteria:
inclusion criteria: * patients with lymphoma or multiple myeloma who are candidates for autohsct * patients \> 18 years old who signed our informed consent * normal cbc count (hb \> 10, wbc 4.0-11.00, plt \> 100,000) exclusion criteria: * patients with hiv, hepatitis c, hepatitis b diagnosis * pregnant women
gait and functional improvement in total knee arthroplasty with the use of verasense for soft tissue balancing

Conditions: Osteoarthritis

Summary: the primary objectives of this study are to understand the effects of soft-tissue balancing on gait, function and rehabilitation potential after sensor-assisted total knee arthroplasty and correlate intra-operative subjective feel with orthosensor outputs secondary objectives are to quantify and observe: * pain medication use * swelling * muscle strength and girth * gait efficiency * patient satisfaction * activity levels, functional return (i.e., back to work, resume normal activities) * patient perception of a balanced knee


Eligibility criteria:
inclusion criteria: * subject must be a candidate for a primary pcl retaining total knee arthroplasty * subject must be diagnosed with one or more of the following conditions: osteoarthritis, avascular necrosis, rheumatoid or other inflammatory arthritis, post-traumatic arthritis * subject is between the age of 45 - 80 years * subject is likely to be available for all study visits * subject is able and willing to sign the informed consent and follow study procedures exclusion criteria: * prior total knee arthroplasty, ligament insufficiencies, prior surgeries such as acl or pcl reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures * range of motion less than 90 degrees, flexion contracture of more than 20 degrees

Keywords: primary pcl-retaining total knee arthroplasty intraoperative sensors ligament balancing clinical outcomes
study evaluating bazedoxifene/conjugated estrogen combinations in symptoms associated with menopause

Conditions: Vasomotor Symptoms Associated With Menopause

Summary: the purpose of this study is to determine whether bazedoxifene/conjugated estrogens combinations are effective in the treatment of moderate to severe vasomotor symptoms associated with menopause.


Eligibility criteria:
inclusion criteria: * generally healthy, postmenopausal women, aged 40 to 64, with last natural menstrual period completed at lease 6 months ago * intact uterus * seeking treatment for hot flushes and experiencing 7 moderate to severe hot flushes per day or 50 per week exclusion criteria: * history of active presence of thrombophlebitis, thrombosis, thromboembolic disorders * history of active presence of stroke, tia, heart attack or ischemic heart disease * history of melanoma, breast or any gynecologic cancer at any time; history of any other cancer within the past 5 years

Keywords: menopause
ultrasound guided blockade of the lumbar plexus - the supra sacral parallel shift

Conditions: Hip Fracture

Summary: anesthesia for hip surgery can be performed with ultrasound guided blockade of the mesh of nerves (the lumbar plexus) supplying the hip region from the lumbar spinal nerves. this is a relevant technique in patients with severe cardiac comorbidity. the technique is a safer alternative compared to general or spinal anesthesia in these fragile patients. the most recognized technique with ultrasound guidance (karmakars technique) is technically demanding and based on injection of local anesthetic relatively close to the exit of the spinal nerves from the spine. the risk is spread of local anesthetic to the spinal canal prompting a risk of low blood pressure. this may be fatal in high risk patients. the investigators have developed a simple technique based on injection away from the spinal canal. the investigators expect minimal risk of spread of local anesthetic to the spinal canal with this technique. this randomized, double blinded trial compares the new technique to the established technique of ultrasound guided blockade of the lumbar plexus. the hypothesis is that the new technique has a higher success rate with reduced effect on blood pressure for ultrasound guided lumbar plexus block compared to the established technique.


Eligibility criteria:
inclusion criteria: * written informed consent * asa i (american society of anesthesiologists physical status classification) exclusion criteria: * volunteers who are not able to cooperate * volunteers who do not understand and speak danish * daily use of analgesics * allergy to local analgesics or contrast agents * abuse of medicine or alcohol * volunteers with technical impediments of the planned interventions
injectable lidocaine versus lidocaine/tetracaine patch for the incision and drainage of skin abscesses

Conditions: Cutaneous Abscess; Pain

Summary: local anesthesia used for incision and drainage of abscesses is known to be painful. we studied the analgesia provided by a lidocaine/tetracaine patch compared to injectable lidocaine during incision and drainage (i\&d) of skin abscesses. local injection of lidocaine provided similar analgesia compared to the lidocaine/tetracaine patch during i\&d of skin abscesses in the emergency department. pain at presentation and following the procedure was similar in both groups.


Eligibility criteria:
inclusion criteria: * age\>18 years * skin abscess in need of incision and drainage (judged by treating physician) exclusion criteria: * allergy to lidocaine or tetracaine * non-intact skin * unable/unwilling to provide informed consent

Keywords: local anesthetic incision and drainage pain cutaneous abscess
reduction of concussion symptoms through the use of osteopathic manipulative therapy

Conditions: Concussion, Brain

Summary: concussion incidence in high school and collegiate sports is high, especially in football. once diagnosed, return to play is dependent on recovery from symptoms followed by a specific protocol for clearance; the sooner the symptoms subside the sooner the protocol is initiated. osteopathic manipulative therapy (omt) is a low risk procedure that has minimal side effects and has been used to decrease both headache intensity and frequency. with the main subjective symptom tracked for concussion being headache, omt may be used to decrease the severity and the duration of this symptom.

concussion incidence in high school and collegiate sports is high, especially in football. these injuries have become the focus of the sports world, as coaches, trainers, and medical personnel are more vigilant than ever in screening for concussions. once diagnosed, return to play is dependent on recovery from symptoms followed by a specific protocol for clearance; the sooner the symptoms subside the sooner the protocol is initiated. osteopathic manipulative therapy (omt) is a low risk procedure that has minimal side effects and has been used to decrease both headache intensity and frequency. with the main subjective symptom tracked for concussion being headache, omt can be used to decrease the severity and the duration of this symptom. in a prospective superiority comparison between standard of care for concussion (rest and return to play protocol) and a single omt treatment in combination with standard therapy, we hypothesize that omt decreases symptom duration and severity of headache in concussion management.

Eligibility criteria:
inclusion criteria: 1. patients referred to the geisinger sports medicine clinic or athletic training room for concussion evaluation and management 2. age less than 25 years old 3. enrolled in high school or college 4. participating in a sport at either collegiate or high school level exclusion criteria: 1. diagnosis does not meet criteria for concussion 2. symptoms of concussion not present on initial visit 3. patient unable to tolerate the omt treatment 4. patient needs intervention beyond standard concussion management 5. patients not able to provide consent to be a part of the study
genetics of women with lobular carcinoma in situ of the breast

Conditions: Breast Cancer

Summary: rationale: gathering information about genetic changes in patients with lobular carcinoma in situ of the breast may help doctors learn more about the disease and find better methods of treatment. purpose: this clinical trial is studying the genetics of women with lobular carcinoma in situ of the breast.

objectives: primary * identify inherited variation that predisposes women to develop lobular carcinoma in situ (lcis) of the breast. * identify the frequency of these variants and determine the effect they have on tumor risk. * determine how worthwhile it would be to test for these variants in the clinical setting so that those at higher risk could be identified, counseled, and screened. secondary * analysis of genetic changes within lcis with the aim of identifying cases of lcis which may progress to invasive cancer. outline: patients and control participants undergo blood collection. dna is extracted from blood samples and used to genotype at selected polymorphisms, compare allele frequencies (used to associate alleles with disease) using a genome-wide single nucleotide polymorphism (snp) screen. archival tumor samples (if available) from patients are used for dna-, rna-, or protein-based analyses. all participants complete a questionnaire about family history, a brief medical history, and provide epidemiological data to a genetic counselor. participants identified to be at risk for known hereditary predisposition to cancer will be referred to a clinical genetics service. individual results of this study are not disclosed to participants. peer reviewed and funded or endorsed by cancer research uk. projected accrual: a total of 2,000 participants (1,000 patients and 1,000 matched controls) will be accrued for this study.

Eligibility criteria:
disease characteristics: * meets 1 of the following criteria: * current or prior diagnosis of lobular carcinoma in situ (lcis) of the breast, including any of the following cases: * pure lcis * lcis with subsequent development of invasive breast cancer of any morphological subtype * lcis presenting as an incidental finding together with invasive breast cancer of any morphological subtype * control participant matched for age and ethnicity to each lcis patient * not affected by lcis * no history of ductal carcinoma in situ of the breast * no breast cancer * no relative (up to 2nd degree) who has been affected by breast cancer * male or female patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: invasive lobular breast carcinoma with predominant in situ component invasive lobular breast carcinoma lobular breast carcinoma in situ
a comparative clinical study of different caries removal techniques in pediatric patients

Conditions: Dental Caries in Children

Summary: the aim of this study is to evaluate the acceptance of pediatric patiens using er: yag laser in comparison with the conventional techniques for caries removal. the study was carried out on 100 children between the ages of 9-12, who had class 1 occlusal caries in one of their permanent first molars. the patients were divided into two groups; conventional technical group and laser group. rotary handpieces was used in conventional technique group, er:yag laser was used in the laser group for caries removal. the heart rate of each patient was measured during the caries removal procedure at 30 seconds intervals. the pain during the procedure was determined by vas. cfss-ds scale was used to determine the anxiety level of the patients before and after the procedure. fis was used to determine how patients are disturbed from the smell, taste, sound, vibration and sight of the devices after the procedure. the video segments were collected from the patients during the caries removal and the procedural pain were evaluated by the flacc scale.

based our results, ın the laser group, the patients were found to experience less pain and discomfort compared to conventional technique according to the vas and flacc scores. the rate of patients with dental anxiety decreased significantly in the laser group compared with the conventional group according to cfss-ds performed after the procedure. according to the sensory survey, the laser group had good acceptability compared to the conventional technique group in terms of vibration and sight. the laser group showed a lower percentage increase in heart rate comparsion between beginning and end of procedure. it was observed that the cavity preparation time was longer in the laser group.

Eligibility criteria:
inclusion criteria: * patients age between 9-12 years old * having no systemic condition and asa 1 healty status * having lower permanent first molar teeth with occlusal caries (class 1) * having no laser treatment before exclusion criteria: * having spontaneous tooth pain * having high dental anxiety * having no restorative treatment before * teeth with periapical pathology, a root filling or non-vital teeth.

Keywords: er:yag laser caries removal dental anxiety acceptability
the impact of motivational interviews conducted through tele-nursing on diabetes management

Conditions: Type 1 Diabetes; Motivational Interviewing

Summary: the deterioration of glycemic control in adolescents with type 1 diabetes (t1dm) is a genuine cause for concern. possible reasons for worsening glycemic control in youth include lack of monitoring, inadequate self-care, psychosocial factors, lack of family support and parental supervision, non-adherence to treatment, pubertal increases in insulin resistance, and insufficient transition from pediatric to adult care. in adolescents with established t1dm who transition to adult-focused care, there is observed disengagement or complete detachment from care. improving glycemic control during adolescence is a critical stage to enhance and reduce complications associated with t1dm. adolescents with t1dm require appropriate daily insulin therapy, regular blood sugar monitoring, physical activity, healthy nutrition, education, and support to delay or prevent diabetes-related complications.this study aims to determine the impact of education and motivational interviews conducted through tele-nursing on the management of diabetes in adolescents with type 1 diabetes.

the study will be conducted with a single-center, single-blind, parallel-group, randomized controlled design with a follow-up period of 6 months.the population of the study consists of 141 adolescents aged 13-18 diagnosed with type 1 diabetes, who are being followed up at the diabetes education unit of evliya çelebi training and research hospital, affiliated with kütahya health sciences university in the province of kütahya, türkiye. the sample of the study will consist of 96 adolescents, with 48 participants in each group, assuming a 1:1 randomization, based on the reference study. in their research, where motivational interviews were used for adolescents' diabetes management, the reported hba1c levels for the study group (9.61±2.40) and the control group with routine follow-up (10.76±2.07) at the 6-month follow-up were considered, aiming for an 80% power and a 0.05 margin of error.

Eligibility criteria:
inclusion criteria: * diagnosed with type 1 diabetes at least 6 months ago * under follow-up at kütahya evliya çelebi health sciences university training and research hospital diabetes education unit * having an hba1c level above 7.5% in the most recent measurement * having a smartphone exclusion criteria: * refusal of legal guardian or the adolescent themselves to participate in the research * difficulty in communication or answering questions * having hearing, speech, vision, or cognitive impairments * being in the honeymoon period of type 1 diabetes * having a second autoimmune disease, such as celiac disease, besides type 1 diabetes
multimodal pain management after wide awake local anesthesia no tourniquet orthopedic hand surgery: a randomized control trial

Conditions: Pain Management

Summary: the main objective of the study is to measure the efficacy of a multimodal postoperative pain regimen consisting of oral acetaminophen and naproxen compared to a traditional opioid-only pain regimen following elective wide awake local anesthesia no tourniquet (walant) hand surgery in a hispanic population. the study is a randomized control trial comparing the clinical outcomes of patients undergoing elective walant hand surgery performed by a board-certified, fellowship-trained orthopedic hand surgeon (dr. christian a. foy). the study groups are: * control group: standard pain control with opioids * experimental group: multimodal non-opioid pain control study outcomes are: * vas pain scores (7 days), * total opioid usage * patient satisfaction * adverse events we hypothesize that patients receiving multimodal pain regimens will report lower opioid use, lower pain scores, and greater satisfaction than patients receiving traditional opioid-only pain management.

the main objective of the study is to measure the efficacy of a multimodal postoperative pain regimen consisting of oral acetaminophen and naproxen compared to a traditional opioid-only pain regimen following elective wide awake local anesthesia no tourniquet (walant) hand surgery in a hispanic population. the study is a single-blind, single-center randomized control trial comparing the clinical outcomes of patients undergoing elective walant hand surgery performed by a board-certified, fellowship-trained orthopedic hand surgeon (dr. christian a. foy). patients will be consecutively recruited at the center and randomized in a 1:1 ratio into the control and experimental groups. the control group will receive the standard of care for postoperative pain: 10 pills of 5mg oxycodone q4hrs as needed. the experimental group will receive 30 pills of 500mg acetaminophen q4hrs and 30 pills of 500mg naproxen q4hrs until pain resolves or treatment is completed. the experimental group will also receive 5 tablets of 5mg oxycodone to take q4hrs as needed for breakthrough pain. postoperatively, daily pain visual analog scale (vas) scores, total opioid usage, patient satisfaction, and adverse events will be recorded. we hypothesize that patients receiving multimodal pain regimens will report lower opioid use, lower pain scores, and greater satisfaction than patients receiving traditional opioid-only pain management.

Eligibility criteria:
inclusion criteria: * patients 21-70 years of age undergoing outpatient hand surgery * patients undergoing surgery with walant technique * patients who provide written informed consent exclusion criteria: * patients aged 20 and younger, or 71 and older * patient with chronic pain requiring opioid use * pregnant patients * patients who do not self-identify as hispanic * patients with known allergy to the medication * patients with contraindications for the prescribed medications

Keywords: walant multimodal analgesia nonopioid pain management vas pain scores
validation of a questionnaire for measuring quality of life in patients with chronic inflammation of the middle ear

Conditions: Chronic Otitis Media

Summary: for measuring quality of life in patients with chronic inflammation of the middle ear, only two questionnaires currently exist. however, these questionnaires are designed only to measure either disease-specific health or hearing-related quality of life. the aim of this project is the validation of a pre-existing comprehensive questionnaire, which is routinely administered in the investigators clinic but has never been validated. following a retrospective item reduction based on existing data, this questionnaire will be prospectively validated. applying the resulting questionnaire in future studies on chronic middle ear inflammation, not only objective outcome parameters (e.g. audiograms) but also quality of life will be assessed. therefore, the investigators questionnaire will add substantial information to these outcome studies by providing a subjective outcome parameter.

see summary that contains all the details

Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic otitis media exclusion criteria: none